Levadex: PD trial data

A double-blind, placebo-controlled, crossover, U.S. pharmacodynamic trial in 24 healthy volunteers showed no significant difference between orally inhaled Levadex and placebo on the primary endpoint of pulmonary artery pressure over 2 hours post treatment. Map also said that pulmonary artery pressure was higher in the IV DHE group vs. Levadex and vs. placebo. The trial was conducted in support of a planned NDA submission in 1H11 for Levadex to treat acute migraine. ...